이상반응 보고
| VAERS ID | 1841889 |
|---|---|
| 성별 | 알 수 없음 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FH4092 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-10-05 |
| 발병일 | 2021-10-05 |
| 상태 | 중증 |
증상
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 조산아(Premature baby)
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임상 검사
증상 상세
Placental separation in gestational week 26; Maternal exposure during pregnancy, second trimester; This is a spontaneous report from a physician reporting information for a child.
This is the third of three reports.
The first report is a report downloaded from the Regulatory Agency-WEB NO-NOMAADVRE-FHI-2021-Urmqw8.
A neonate patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 transplacental on 05Oct2021 (Batch/Lot Number: FH4092) as DOSE 2, SINGLE for covid-19 immunisation.
The patient's medical history and concomitant medications were not reported.
Historical vaccine included the patient's mother received first dose of Comirnaty on 27Aug2021 (Batch/lot number: FG2975) for covid-19 immunisation and experienced Maternal exposure during pregnancy, second trimester.
The patient's pregnant mother experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty on 17Oct2021.
The child (patient) was delivered by emergency Caesarean section.
The outcome of the events was unknown.
The event "Placental separation in gestational week 26" was reported as serious due to life-threatening.
Reporter comment: Pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty.
The patient was admitted to hospital with massive intrauterine haemmorhage.
The child was delivered by emergency Caesarean section.
The patient is retrospectively evaluated for possible risk factors but none was found.
The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.
No follow-up attempts possible.
No further information expected.
; Reporter's Comments: Pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty.
The patient was admitted to hospital with massive intrauterine haemmorhage.
The child was delivered by emergency Caesarean section.
The patient is retrospectively evaluated for possible risk factors but none was found.
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); Sender's Comments: Linked Report(s) : NO-PFIZER INC-202101474307 mother case;NO-PFIZER INC-202101461768 mother case